Clinical Trial: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Brief Summary: The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.

Detailed Summary:
Sponsor: Aleš Rozman

Current Primary Outcome: diagnostic adequacy of semirigid thoracoscopy [ Time Frame: 12 months ]

  • comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group)
  • size of the biopsy specimens in mm2
  • interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)


Original Primary Outcome: Same as current

Current Secondary Outcome: safety [ Time Frame: 1 month ]

Major adverse events:

  • bleeding
  • infection
  • reexpansion pulmonary edema

Minor adverse events:

  • transient self-limited fever
  • pain
  • prolongued air leak

  • subcutaneous emphysema

    30-day mortality



Original Secondary Outcome: Same as current

Information By: The University Clinic of Pulmonary and Allergic Diseases Golnik

Dates:
Date Received: May 31, 2011
Date Started: January 2008
Date Completion:
Last Updated: November 9, 2011
Last Verified: November 2011